For All Your Regulatory Affairs Needs

About me

My name is Michelle Riddalls and I am a commercially and strategically aware Regulatory Consultant, with 15 years of Regulatory Affairs experience, 12 of which in the OTC sector. 

I am an organised leader with the proven ability to manage others to reach key objectives. I have strong decision making, problem solving and planning skills.  I am an excellent cross functional team player and I am used to developing and implementing innovative solutions. I have highly effective communication skills and have the ability to influence key internal and external stakeholders, both nationally and internationally.  

My Key Skills and Achievements

  • Ensuring marketing authorisation approval and implementation of changes within critical business timelines
  • Cross functional team work with the ability to lead and manage people in both New Product Development (NPD) and Product Changes
  • Managed and completed specific special projects on a regular basis e.g. User Testing, Change of Name and Address
  • Using initiative and strategic thinking to develop and implement effective solutions to problems and aid NPD and product approvals
  • Strong interpersonal and communication skills, used to influence agencies, external and internal stakeholders and colleagues nationally and internationally to align to key commercial deadlines and project requirements
  • Planning and organising workload, using project management skills
  • Coordination of projects and input into working groups with industry association PAGB
  • Identify process improvements and write new and efficient operating procedures to support the changes
  • Audit management and preparation
  • Writing position papers on latest UK government initiative "Red Tape Challenge"

Technical and Specialised Skills

Strategic advice on NPD and Product Changes

Rebrands and artwork, including Patient Information Leaflets writing

Reclassifications of medicines POM to P and P to GSL
 

SOP writing 

Manufacturing transfers

Reformulations

MA submissions and responses

Systems and Process Optimisation, Management and Training

Documentum Management – design, management and validation

 Position Papers

 User Testing

Project Management of major changes to products


View my profile on LinkedIn